Mapi Pharma Granted United States Patent Covering the Process for the Preparation of Fingolimod for Multiple Sclerosis
The patent covers intermediate compounds and processes for the preparation of Fingolimod
Ness Ziona, Israel, February 18, 2014 ---- Mapi Pharma Ltd. ("Mapi" or the "Company"), a developer of high-barrier to entry and high value-added generic drugs that include complex active pharmaceutical ingredients ("APIs"), formulations and life cycle management ("LCM") products that target large markets, announced today that it was granted a United States patent covering the process for the preparation of Fingolimod, a drug currently marketed by Novartis under the trade name Gilenya. Novartis reported sales of Fingolimod of $1,934 million in 2013, representing a 62.0% increase from 2012. With the issuance of this patent, Mapi intends to develop a generic version of Fingolimod for sale once Novartis loses its marketing exclusivity, commencing as early as 2017 in certain markets.
U.S. Patent Application No. 13/881,961 is titled Intermediate Compounds and Processes for the Preparation of Fingolimod. Fingolimod is an immunomodulating drug, approved for treating multiple sclerosis. Fingolimod is a sphingosine 1-phosphate receptor modulator, which sequesters lymphocytes in lymph nodes, preventing them from contributing to an autoimmune reaction.
"Fingolimod is another key product in our MS portfolio that includes Glatiramer Acetate Depot (US Patent number 8,377,885 B2) to be administered once-a-month, rather than daily or thrice weekly as is currently available, and a new chemical entity ('NCE'), a novel pentapolymer. Today's news strengthens Mapi's patent position, supports its business plan and advances the company one step closer to building a complete medicinal portfolio for MS," said Mapi chairman and chief executive officer, Mr. Ehud Marom.
MS is a chronic, often disabling disease that attacks the central nervous system. Symptoms include numbness in the limbs, paralysis and loss of vision. Symptoms are unpredictable and differ from one person to another. Based on Thomson Reuters Cortellis' website, the global market for MS pharmaceuticals was estimated to be in excess of US $15 billion in 2013.
Mapi Pharma Ltd. ("Mapi" or the "Company") is a developer of high-barrier to entry and high value-added generic drugs that include complex active pharmaceutical ingredients ("APIs"), formulations and life cycle management ("LCM") products that target large markets. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs and its ability to foster local cooperation and enduring relationships in all of the countries in which it operates. Mapi is dedicated to providing generic and innovative intermediates and APIs, as well as developing finished dosage forms - either for Mapi's internal API program, as a vertically integrated company, or as generics of leading brands. Mapi is headquartered in Israel. It has R&D facilities in Israel, China and Germany and is currently building an API manufacturing site in Neot Hovav, Israel's designated chemical park. Mapi has a strong IP position, filing more than 20 patent applications for APIs and formulations in less than three years of operation. For more information: www.mapi-pharma.com.
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